OPP002 📄 Overview A SaMD platform designed for patients transitioning from acute care (e.g., post-surgery, stroke recovery, heart failure exacerbation). It combines continuous physiological monitoring (wearables/sensors), personalized digital therapeutics (e.g., virtual physical therapy, cognitive rehab modules), and an AI-driven alert system for clinicians. Features include medication adherence tracking, symptom journaling, and secure telehealth integration. Key technologies: 👤 Target users: 👍 Benefits Reduced re-admissions rates • Improved patient recovery and functional outcomes • Enhanced medication adherence and symptom management • Increased access to continuous specialized care Use bullets or new lines. 👎 Challenges Interoperability with existing EHRs and hospital systems • Ensuring device accuracy and reliability in varied home environments • Training clinicians and patients on new technology • Reimbursement pathways for integrated solutions 📋 Regulatory & Validation Likely Class II SaMD for monitoring and therapeutic guidance. • Clinical validation of therapeutic modules and predictive algorithms. • ISO 13485 for quality management and cybersecurity compliance.